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According to the most up-to-date details accessible to the Company, the critique of the Libervant NDA for pediatric sufferers aged two to 5 remains on the right track and there are at present no outstanding info requests with the FDA. The NDA for Libervant was assigned a PDUFA focus on motion day of April 28, 2024.
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“In regards to the cure of seizure clusters in pediatric sufferers with epilepsy amongst ages two to five, we imagine Libervant, as an oral alternate to existing product-based mostly solutions, will likely be well-obtained by this affected person inhabitants.”
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